Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). METHODS: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. RESULTS: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. CONCLUSION: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331).

[Efficacy and safety evaluation of two insulin treatment protocols using a continuous glucose monitoring system].

OBJECTIVE: To evaluate the efficacy and safety of two insulin treatment protocols using a continuous glucose monitoring system. METHODS: Type 2 diabetic patients mellitus with unsatisfactory control of fasting blood glucose by oral antidiabetic drugs were included in the study. The patients were randomized into two groups to receive bedtime injection of glargine and oral antidiabetic drugs (group A) or injection of Novolin 30 R twice a day (group B) for 12 weeks. The insuline dose was adjusted according to fasting blood glucose till discharge. Continuous glucose monitoring system was used to record the average blood glucose, fasting blood glucose, 2 h postprandial blood glucose, AUCPG ≥ 10.0 mmol/L%, HbA1c and C peptide, bedtime blood glucose, 3:00 AM blood glucose, the incidence of hypoglycemia and body mass index. RESULTS: The average blood glucose, fasting blood glucose, 2 h postprandial blood glucose, AUCPG ≥ 10.0 mmol/L% and HbA1c was significantly decreased and C peptide significantly increased in the two groups after the treatments. The patients in glargine group showed better improvement with a significantly lower incidence of hypoglycemia than those in Novolin 30 R group. BMI underwent no significant changes in the two groups after the treatments. CONCLUSION: Glargine therapy better mimics the physiological insulin secretion patterns, and when combined with oral antidiabetic drugs, can be more effective and safer than premixed insulin.

[Epidemiological investigation of diabetes and prediabetes in community residents in the suburbs of Guangzhou].

OBJECTIVE: To identify the prevalence and risk factors of diabetes and prediabetes in the community residents above 18 years old in the suburbs of Guangzhou. METHODS: Between April and May in 2008, the residents above 18 years living in 6 communities of Guangzhou for 5 or more years were sampled with multistage clustering sampling. The sampled residents were surveyed by questionnaires, and physical examination and glucose determination were carried out. RESULTS: A total of 1532 residents were sampled. The incidence of diabetes mellitus in these community residents was 8.46%, and that of impaired glucose regulation was 6.59%. Age, body mass index, family history of diabetes mellitus, case history of hypertension, hyperlipidemia, hypertension and smoking were all the independent risk factors for impaired glucose regulation and diabetes mellitus. CONCLUSION: Diabetes and prediabetes are prevalent in the community residents in Guangzhou. Controlling the risk factors such as obesity, hypertension, lipid metabolism disorder among the residents above 40 years with a family history of diabetes mellitus and hypertension is key to prevention of impaired glucose regulation and diabetes mellitus.